Calcium
Phosphate
Cement
Fast-Setting Bone Graft
and AutoGraft Extender.*
Advantages
Ossilix is a high performance next
generation calcium phosphate
cement indicated for filling bony
defects in cancellous bone.
•
Biocompatible
•
Allows for natural bone remodeling, or healing, while still
maintaining the strength above that of cancellous bone
– Immediate higher compressive strength than
cancellous bone
This material was designed to overcome the limitations
•
Easy to mix and deliver with supplied mixing system
•
Fast, hard-setting; approximately 6 minutes at 37°C in
wet environment*
of the first generation calcium phosphate cements.
First generation cements had good compression strength,
•
Can be drilled and inserted with screws
•
May be implanted before or after hardware allowing
surgeons to maintain their standard surgical technique
and allowing precise cement and hardware placement
but were weak in tension, flexural strength and
•
fracture toughness, which combined with
Can be mixed with autograft as autograft extender*
poor handling properties, have limited their use
in fracture fixation.
Clinical Applications
•
Simple voids in metaphyseal bone,
(small tumors, cysts, defects)
•
Traumatic fractures that result in bone voids in
metaphyseal areas
Ossilix Form
Moldable
Ossilix Fil
Injectable
Fractures of the:
--
Distal radius (colles)
--
Proximal humerus
--
Pelvic bone
--
Proximal femur (intertroch, femoral neck)
--
Distal femur
--
Tibial plateau
--
Tibial pilon
--
Calcaneus
•
Osteotomies (distal radius, tibial plateau)
•
All oncological applications
•
Revision total joints
•
Iliac crest backfill
•
Autograft extender*
*Ossilix form
3
Science
Remodeling Case Study
DRILLABLE OSTEOCONDUCTIVE SCAFFOLD
Composition
Biomechanical Analysis
Bone remodeling is the healing process whereby old bone is naturally removed
A clinically relevant understanding of long-term strength of
and replaced with new bone. Ossilix is similar in composition to the mineral
defects treated with calcium phosphate bone void fillers (or
phase of bone.
any other bioactive material) are appropriately evaluated only
in vivo. An in vivo biomechanical study was performed at four
A calcium phosphate starting powder is reacted with diluted silicate liquid,
weeks and six months post-implantation to assess the in vivo
and undergoes a non-exothermic chemical reaction to form low crystalline
strength of cancellous bone defects treated with Ossilix bone
hydroxyapatite, which hardens in vivo to create an Osteoconductive scaffold.
void filler during replacement by native cancellous bone.
Bony ingrowth occurs through the same cell mediated process as the patient’s
Patterns show X-ray diffraction
showing Ossilix and bone
have the same chemical and
crystalline composition.
Ossilix is radiopaque and visible under fluoroscopy to
natural bone remodeling.
Pre-op:
shows the calcaneus void
after fracture.
allow proper placement of hardware and to ensure the
Ossilix is optimal as a filler for metaphyseal defects due to its high immediate
cancellous defect has been completely filled.
mechanical strength and ability to maintain that strength long term throughout
Ossilix can be drilled and inserted with a screw to optimize
the healing process.
use of the combination of hardware and cement, essential
Histology
in treating periarticular fractures. Ossilix Form can accept
Histology analysis demonstrated that Ossilix is highly biocompatible and
hardware after a setting time of 6 minutes in vivo, and Ossilix
osteoconductive. Histological sections were examined following four weeks
Fil can accept hardware after setting 10 minutes in vivo.
and six months in vivo and showed extensive bone apposition with no adverse
Ossilix should be drilled only with fluted bits or screws.
tissue reaction. Normal bone remodeling by localized osteoclastic, cell mediated
resorption coupled with new bone formation within the implanted area was a
Post-op:
shows the amount of
Ossilix implanted.
consistent finding in areas implanted with Ossilix.
An in vivo study shows Ossilix maintains strength
above cancellous bone as it gets remodeled.
350
300
Figure 1
Femoral specimen implanted with bone cements after one month. Formation
of several Haversian canals were observed in and around the implanted region. (Trichrome staining)
Load (Newton)
250
Post-op 1 year:
Remodeling of Ossilix is
evidenced by reduction in
density of the implanted area.
318
278
200
150
100
130
50
0
4 weeks
Figure 2
6 months
Bone (Control)
Post-op 2 years:
As material continually remodels,
radiographic evidence of the
implanted area returning to
trabecular structure.
Femoral Specimen implanted with Ossilix after six months at low (left) and high (right) magnification.
Mature Haversian canals were seen in areas where Ossilix was
originally implanted. (HE staining)
4
5
Indications & Case Studies
Total Joint Revision
TRAUMA
Tibial Plateau Fracture
Pre-op
view shows extensive osteolysis
in both compartments of tibial bone
underneath the tibial tray.
Pre-op
CT shows low energy Tibial Plateau fracture
Intra-op
view of filling the bony voids with Ossilix.
Post-op
view of Ossilix implant and new total knee joint
has been inserted.
Post-op
X-ray shows the fixation by plating and
Ossilix implantation
Distal Radius Fracture
Pre-op
Pre-op
X-ray showing on extra-articular fracture.
Lateral view
shows Ossilix implantation in both dorsal and
volarside of distal radius.
Post-op
Shoulder riding high
compromised glenoid
Post-op
10cc Ossilix Inject to fill voids and to
Strengthen Glenoid Component
4 Months
Showing significant bone remodeling
and glenoid component solid
image of implantation of Ossilix with K-wires.
ONCOLOGY
Calcaneus Fracture
10cc Implant
10cc Implant
Post-op
lateral image of calcaneus shows fixation
with plate and Ossilix.
6
Post-op
AP view shows the location of
implanted Ossilix.
Pre-op
MRI view of atypical bone cyst.
Post-op
radiograph shows complete filling
of the defect in calcaneus.
Giant cell tumor of tibia.
Radiographic view shows complete
filling with Ossilix. Approximately
80cc of material was used.
7
Ordering Information
Name
Description
Catalog
Ossilix / Form
Calcium Phosphate Fast Setting, 5cc
660-01-05
Ossilix / Form
Calcium Phosphate Fast Setting, 10cc
660-01-10
Ossilix / Fil
Calcium Phosphate Fast Setting, 5cc
660-02-05
Ossilix / Fil
Calcium Phosphate Fast Setting, 10cc
660-02-10
Ossilix is manufactured by Skeletal Kinetics and distributed by
Exactech Inc.
References
1.
2.
3.
4.
5.
Lin, J., et al. Improved Flexural Strength of a Novel Craniomaxillofacial Cement.
Orthopaedic Research Society Transactions Vol.30, Washington, D.C., 2005.
Banki, P., et al. Optimization of the Osteoinductiveness and Mechanical
Properties of Calcium Phosphate Bone Cement using Demineralized Bone Matrix.
Orthopaedic Research Society Transactions Vol.29, San Francisco, California,
2004.
Yetkinler, D N., et al. In Vitro and In Vivo Evaluation of Two Calcium Phosphate
Cements. Orthopaedic Research Society Transactions Vol.29, San Francisco,
California, 2004.
Lin, J., et al. Increased Fracture Toughness Improves Clinical Utility of a Novel
Calcium Phosphate Cement. Orthopaedic Research Society Transactions Vol. 31,
Chicago, Illinois
McDonald E., et al. Lateral Tibial Plateau Fracture Split Depression Fracture
Repairs Augmented with Calcium Phosphate Cement Have Higher In Situ Fatigue
Strength than those with Autograft. Journal of Orthop Trauma, 2011;25(2):90-5.
6.
7.
8.
9.
Muehrcke, D.D., et al. Calcium Phosphate Cements Improve Bone Density When
Used in Osteoporotic Sternums. Annuals of Thoracic Surgery, 2009; 88:1658-61
Muhonen M.G., et al. Hydroxyapatite cement resistant to fragmentation following
full cerebrospinal fluid bathing. Journal of Craniofacial Surgery. 2008. 19(1): 283-6.
Vaughn Z., et al. Biomechanical Evaluation of a 1-Stage Revision Anterior Cruciate
Ligament Reconstruction Technique Using a Structural Bone Void Filler for
Femoral Fixation. Journal of Arthroscopic and Related Surgery, 2009;25:1011-1018
Jalota , S. et al. In vivo assessment of Ossilix/OsteoVation calcium phosphate
cement containing autologous bone. Annual Meeting, Society for Biomaterials,
April 21 – 25, 2010, Seattle, WA.
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